Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The project Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia investigates the safety and efficacy of low-dose thalidomide in managing beta thalassemia, a genetic disorder causing anemia. Conducted over two years at NIBD hospital, the study involves 54 transfusion-dependent patients aged 8-35. The primary objective is to correlate thalidomide doses with disease severity, adverse effects, and treatment response, aiming to optimize treatment strategies and reduce side effects. Data will be collected through clinical interviews and medical record reviews and analyzed using SPSS. Key variables include hemoglobin levels, leukocyte and reticulocyte counts, platelets, liver and spleen size, genetic modifiers, and transfusion frequency. Inclusion criteria are specific to beta thalassemia patients, while exclusion criteria rule out those with liver dysfunction, married patients, lactating mothers, and those with a history of thrombosis or fits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 35
Healthy Volunteers: f
View:

• Know case of beta thalassemia major/ intermediate ( transfusion dependent)

• willing to give informed consent

Locations
Other Locations
Pakistan
National Institute of blood disease and bone marrow transplant
RECRUITING
Karachi
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2026-04-22
Participants
Target number of participants: 54
Treatments
No_intervention: Control
in this group, patient will not receive any interventional drug or treatment drug so simply they will blood transfusion dependent.
Experimental: Group 1 Thalidomide
In this group , thalassemia patients will receive thalidomide at the dose of 5-6mg/kg/day at night with aspirin.
Active_comparator: Group 2 Thalidomide
In this group , thalassemia patients will receive thalidomide at the dose of 7-8mg/kg/day at night with aspirin
Sponsors
Leads: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

This content was sourced from clinicaltrials.gov